Medical device recalls Moderate risk

Zimmer, Inc. recalls Brand Name: Disposable Mixing Bowls with Spatula Product Name: Mixing Bowl and Spatula Model/Catalog Number: 00-5049-01…

Recall date
March 30, 2026
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1946-2026
FDA classification
Class II
Brand / firm
Zimmer, Inc.
Sold / distributed
US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, MD, MI, MO, MS, NC, NE, NM, NY, OH, OK, PA, SD, TN, TX, UT, WA, WI and the countries of Canada, Australia, New Zealand, Malaysia, EMEA, Chile.

Why it was recalled

Ten complaints have been received identifying issues at the time of use related to the package seal, including incomplete seals, wrinkles in the seals or peeling seals. Compromised sterile barrier may lead to clinically insignificant extension of surgery or infection leading to surgical intervention.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Brand Name: Disposable Mixing Bowls with Spatula Product Name: Mixing Bowl and Spatula Model/Catalog Number: 00-5049-011-00 Software Version: N/A Product Description: Mixing Bowl and Spatula Component: N/A

Get recall alerts

Free email alert whenever Zimmer, Inc. has a new recall — straight from official government data. Unsubscribe anytime.

More recalls from: Zimmer, Inc.